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How to renew marketing authorisations for products granted through different routes and at different times.
How to change the ownership from one marketing authorisation (MA) holder to another.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Guidelines to help mitigate and manage medicine shortages.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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